Central endoscopy reads in inflammatory bowel disease clinical trials:The role of the imaging core lab

作     者：Harris Ahmad Tyler M.Berzin Hui Jing Yu Christopher S.Huang Daniel S.Mishkin 

作者机构：Medical AffairsBioClinica Inc.NewtownPennsylvaniaUSA Division of GastroenterologyBeth Israel Deaconess Medical CenterHarvard Medical SchoolBoston MAUSA Section of GastroenterologyBoston Medical CenterBoston University School of MedicineBostonMAUSA Division of GastroenterologyGranite Medical GroupBoston Medical CenterBostonMAUSA 

出 版 物：《Gastroenterology Report》 (胃肠病学报道（英文）)

年 卷 期：2014年第2卷第3期

页      面：201-206页

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：GI Reviewers  LLC 

主　　题：inflammatory bowel disease clinical trials imaging core laboratorie 

摘      要：Clinical trials in inflammatory bowel disease(IBD)are evolving at a rapid pace by employing central reading for endoscopic mucosal assessment in a field that was,historically,largely based on assessments by local *** transition from local to central reading carries with it numerous technical,operational,and scientific challenges,many of which can be resolved by imaging core laboratories(ICLs),a concept that has a longer history in clinical trials in a number of diseases outside the realm of *** IBD trials,ICLs have the dual goals of providing objective,consistent assessments of endoscopic findings using central-reading paradigms whilst providing important expertise with regard to operational issues and regulatory *** review focuses on current approaches to using ICLs for central endoscopic reading in IBD trials.